EpilepsyPhase 3NCT05722951
Metformin Efficacy and Safety in Epileptic Patients
A Phase 3 study testing Levetiracetam &/or sodium valproate and Metformin in people with Epilepsy, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is: Does metformin have beneficial effect on epileptic patients? How metformin can affect epileptic patient's health? Participants… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Levetiracetam &/or sodium valproate and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2022to 20 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years old
- Obese and overweight patients with body mass index (BMI) ≥ 25.
- Diabetic \& non diabetic patients.
Who cannot join
- Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²).
- Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction).
- Patients who are already taking metformin.
- Cancer patients.
- Pregnant or lactating women.
- Patients with known hypersensitivity to the drug.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is:
- Does metformin have beneficial effect on epileptic patients?
- How metformin can affect epileptic patient's health?
Participants will be divided into 2 groups (control group and treatment group)
- Control group will receive standard treatment (levetiracetam \&/or sodium valproate).
- Treatment group will receive standard treatment (levetiracetam \&/or sodium valproate) + metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam &/or sodium valproateDrug
Also called Levetiracetam &/or valproic acid
levetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months
MetforminDrug
metformin + (levetiracetam \&/or sodium valproate) will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Control group (+ve control) | Active comparator | levetiracetam \&/or sodium valproate Receives: Drug: Levetiracetam &/or sodium valproate |
| Treatment group | Experimental | metformin + (levetiracetam \&/or sodium valproate) Receives: Drug: Levetiracetam &/or sodium valproate; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizures Frequency
will be recorded using seizures diary.
Measured: 6 months
Seizures Severity
will be measured using chalfont seizures severity scale.
Measured: 6 months
Quality of Life level
will be recorded using SF-36 health survey.
Measured: 6 months
Secondary outcomes (2)
Change in BMI
Measured: 6 months
Change in biological markers
eg. serum lactate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start18 Oct 2022
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Ashraf Abd El Aziz Ahmed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722951
- Sponsor's protocol ID
- 0107353
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Efficacy and Safety in Epileptic Patients
- ClinicalTrials.gov ID
- NCT05722951
- Acronym / sponsor ID
- 0107353
- Conditions
- Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is:
- Does metformin have beneficial effect on epileptic patients?
- How metformin can affect epileptic patient's health?
Participants will be divided into 2 groups (control group and treatment group)
- Control group will receive standard treatment (levetiracetam \&/or sodium valproate).
- Treatment group will receive standard treatment (levetiracetam \&/or sodium valproate) + metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (+ve control) | Active comparator | Drug: Levetiracetam &/or sodium valproatelevetiracetam \&/or sodium valproate |
| Treatment group | Experimental | Drug: Levetiracetam &/or sodium valproate, Drug: Metforminmetformin + (levetiracetam \&/or sodium valproate) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 - 65 years old
- Obese and overweight patients with body mass index (BMI) ≥ 25.
- Diabetic \& non diabetic patients.
Key exclusion criteria (6 listed)
- Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²).
- Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction).
- Patients who are already taking metformin.
- Cancer patients.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam &/or sodium valproateAlso: Levetiracetam &/or valproic acidlevetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months | Drug | Control group (+ve control), Treatment group |
| Metforminmetformin + (levetiracetam \&/or sodium valproate) will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months | Drug | Treatment group |
Primary outcome
Seizures Frequency
Time frame: 6 months
will be recorded using seizures diary.
Seizures Severity
Time frame: 6 months
will be measured using chalfont seizures severity scale.
Quality of Life level
Time frame: 6 months
will be recorded using SF-36 health survey.
2 secondary outcomes
Change in BMI
Time frame: 6 months
Change in biological markers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam &/or sodium valproate and Metformin in people with Epilepsy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizures Frequency (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.